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EP4100088B1 - Vorrichtung zur ausgabe eines mit inhalation synchronisierten flüssigproduktes und verfahren zum zusammenbau dieser vorrichtung - Google Patents

Vorrichtung zur ausgabe eines mit inhalation synchronisierten flüssigproduktes und verfahren zum zusammenbau dieser vorrichtung Download PDF

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Publication number
EP4100088B1
EP4100088B1 EP20707723.1A EP20707723A EP4100088B1 EP 4100088 B1 EP4100088 B1 EP 4100088B1 EP 20707723 A EP20707723 A EP 20707723A EP 4100088 B1 EP4100088 B1 EP 4100088B1
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EP
European Patent Office
Prior art keywords
inhalation
blocking element
blocking
actuating member
actuation
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
EP20707723.1A
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English (en)
French (fr)
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EP4100088A1 (de
Inventor
David Fabien
Matthieu CAVATORTA
Jérémy TOURNOIS
Matthieu WALTER
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Aptar France SAS
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Aptar France SAS
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Publication of EP4100088A1 publication Critical patent/EP4100088A1/de
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Definitions

  • the present invention relates to a fluid product dispensing device synchronized with inhalation, and more particularly an aerosol type inhalation device synchronized with inhalation.
  • BAI Battery Actuated Inhaler
  • BAI Battery Actuated Inhaler
  • the main advantage of this type of device is that the distribution of the product is synchronized with the patient's inhalation, to guarantee good distribution of the product in the respiratory tract.
  • many types of inhalation trigger devices have been proposed. These devices, however, have the disadvantage of comprising a large number of parts, that is to say that they are complicated and expensive to manufacture and assemble, which is obviously disadvantageous.
  • the present invention aims to provide a fluid product distribution device synchronized with inhalation which does not reproduce the aforementioned drawbacks.
  • the present invention also aims to provide a fluid product distribution device synchronized with inhalation which improves operating reliability, by guaranteeing efficient actuation and dosage precision with each inhalation.
  • the present invention also aims to provide a fluid product distribution device synchronized with inhalation which minimizes the risks of accidental or unwanted actuation.
  • the present invention also aims to provide a fluid product distribution device synchronized with inhalation which minimizes the risk of leakage in the valve, before and/or after inhalation.
  • the present invention also aims to provide a fluid product distribution device synchronized with inhalation which does not have a trigger threshold that is too high, thus allowing relatively weak people, such as sick or elderly people, to use the device safely and reliably.
  • the present invention also aims to provide a fluid product distribution device synchronized with inhalation which is simple and inexpensive to manufacture and assemble.
  • the present invention also aims to provide a fluid product distribution device synchronized with inhalation which avoids the risks of valve malfunction due to poor filling of the valve chamber after actuation.
  • said device comprises a movable cover, in particular pivoting on the body, between a closing position of the mouthpiece and an opening position of the mouthpiece, said cover cooperating with said actuating member such that 'in the closed position, it blocks said actuating member against axial movement in the body, and when it is returned from its open position to its closed position, it returns the actuating member to its position rest by recharging said spring.
  • said blocking element is pivotally mounted on the body around a pivot axis B and said trigger element is pivotally mounted on the body around a pivot axis C, said axes B and C being parallel.
  • said lower axial edge is thermally deformed by a heating tool.
  • the device includes an indicator to indicate to the user that the distribution of fluid product has been carried out.
  • said indicator is a visual and/or audible indicator.
  • the device includes an electronic counter.
  • said step of fixing said pre-assembled subassembly on said body is carried out by screwing or snap-fastening.
  • said step of deforming said lower axial edge of said central axial sleeve is carried out by means of a heating tool which thermally deforms said lower axial edge.
  • said actuating member cooperates with said thrust member, to axially push said thrust member into said cover to load said spring.
  • the terms “upper”, “lower”, “top” and “bottom” refer to the position of the device represented in particular on the figures 1 to 9 And 13 to 15 .
  • the terms “axial” and “radial”, unless otherwise specified, refer to the vertical center axis of the valve.
  • proximal and distal refer to the mouthpiece.
  • the invention applies more particularly to inhalation devices of the aerosol valve type for oral distribution, as will be described in more detail below, but it could also apply to other types of devices. inhalation, for example of the nasal type.
  • the device comprises a body 10 provided with a mouthpiece 400.
  • the body 10 can be made in a single piece or in several pieces assembled together.
  • Figure 12 shows an example in which the body 10 is formed of two half-shells, but other implementations are possible. In the remainder of the description, the body will be designated globally by the numerical reference 10.
  • the mouthpiece 400 defines a dispensing orifice through which the user will inhale when using the device.
  • the mouthpiece 400 can be made in one piece with the body 10. In the examples shown in the drawings, it is assembled on a lower part of the body 10.
  • a removable protective cover 1 is provided to cover said mouthpiece 400, particularly during storage periods.
  • This cover 1 is movable, preferably by being pivotally mounted on the body 10, between a closed position, visible on the figures 1 , 8 , 9 And 13 , and an opening position, visible on the figures 2 to 7 , 14 and 15 .
  • the body 10 contains a reservoir 100, containing the product to be distributed and a propellant gas, such as an HFA type gas, a metering valve 200 being mounted on said reservoir 100 to selectively distribute the product.
  • the metering valve 200 comprises a valve body and a valve 210 axially movable during actuation relative to said valve body, and therefore relative to said reservoir 100, between a rest position and an actuation position.
  • This metering valve 200 can be of any suitable type. It is fixed to the reservoir 100 by a suitable fixing element, preferably a crimped capsule, preferably with the interposition of a neck seal.
  • the valve 210 is fixed relative to the body 10, and it is the reservoir 100 which is moved axially relative to the body 10 between a distal position, which is the rest position, and a position proximal, which is the actuation position.
  • valve 210 of said dosing valve 200 is connected via a channel to said mouthpiece 400, through which the user inhales the dispensed product.
  • said valve 210 is received in a valve well 700 which at least partially defines said channel.
  • An actuating member 800 is advantageously assembled around the reservoir 100.
  • This actuating member 800 comprises a hollow sleeve disposed in the body 10 around the reservoir 100.
  • a thrust member 810 is mounted on the distal axial edge of said actuating member.
  • actuation 800 said pushing member 810 being received in a cover element 11 fixed on the upper axial edge of said body 10.
  • a spring 850 is disposed between a bottom of said cover element 11 and said pushing member 810. In the rest position , and until inhalation, the spring 850 is preloaded, and therefore exerts an axial force F on the thrust member 810 which transmits this force to the actuator member 800.
  • the actuator member 800 is movable axially, in particular sliding, relative to said body 10 between a rest position and an actuation position.
  • a lower edge 802 of the actuating member 800 cooperates with the cover 1 such that in the closed position of the cover 1, said actuating member 800 is blocked in position rest, the lower edge 802 being abutting on a part 3 of said cover 1.
  • said cover 1 comprises a cam 4 which cooperates with said lower edge 802 when the cover 1 is returned from its open position to its closed position, to return said actuating member 800 from its actuation position to its rest position.
  • the actuating member 800 returns to its rest position, it also brings back the pushing member 810, which causes the compression of the spring 850.
  • the spring 850 is therefore recharged after each actuation when the user closes the cover 1.
  • the device comprises a blocking element 500 movable and/or deformable between a blocking position, in which said metering valve 200 cannot be actuated, and an actuation position, in which said metering valve 200 can be actuated.
  • the blocking element 500 is advantageously pivotally mounted on the body 10 around an axis B (better visible on the figures 16 to 18 ) between the blocking position and the actuation position.
  • said blocking element 500 Before inhalation, said blocking element 500 is in the blocking position, and it is the user's inhalation through the mouthpiece 400 which moves and/or deforms said blocking element 500 towards its actuation position.
  • actuation of the dosing valve 200 is impossible, and it is only when he inhales that said dosing valve 200 can be actuated, by axial movement of the tank 100 in the body 10.
  • the blocking element 500 in the blocking position, prevents the axial movement of the actuating member 800 in the body 10.
  • this blocking element 500 is moved and/or deformed such that it no longer blocks the axial movement of the actuating member 800 in the body 10.
  • such an axial movement of the actuating member 800 causes the axial movement of the reservoir 100 and therefore the actuation of the dosing valve 200 and the distribution of a dose of product synchronized with this inhalation.
  • a blocking part 2 of the cover 1 cooperates with a projecting part 503 of the blocking member 500 to block the latter in the blocking position, as visible in particular on the figure 1 .
  • This blockage is removed when cover 1 is opened.
  • Opening the cover 1 therefore releases two blocks provided by the cover in the closed position: on the one hand the blocking in axial movement of the actuating member 800 and on the other hand the blocking in pivoting of the blocking member 500.
  • the device comprises a trigger system controlled by the user's inhalation, which is intended to move and/or deform said blocking element 500 from its blocking position towards its actuation position, when the user inhales through it. the mouthpiece 400.
  • This trigger system comprises an organ sensitive to inhalation 60 which is deformable and/or movable under the effect of inhalation, this organ sensitive to inhalation 60 being adapted, when it deforms and/or moves, to allow the movement and/or deformation of said blocking element 500 from its blocking position towards its actuation position.
  • the organ sensitive to inhalation can be produced in the form of a deformable air chamber 60, for example a bellows or a deformable pocket.
  • the trigger system controlled by the inhalation is not located in the flow of the user's aspiration but is formed by a specific chamber, namely the air chamber 60.
  • the system operates in depression and the user only sucks in the small volume of air which was inside the air chamber 60 before its deformation.
  • the system according to the invention is thus much more stable and efficient.
  • the blocking element 500 comprises at least one, preferably two blocking extensions 501, which each cooperates in the blocking position with an axial projection 801 of the actuating member 800.
  • Figure 29 represents a perspective view of this blocking element 500.
  • each blocking extension 501 moves out of contact with the respective axial projection 801.
  • said blocking element 500 comprises, adjacent to each blocking extension 501, an axial recess 502, visible on the Figure 18 , in which the respective axial projection 801 can slide axially, to thus allow axial sliding of said actuating member 800 in said body 10, causing the axial movement of the reservoir 100 and the actuation of the valve 200 with the distribution of a dose of fluid product.
  • the blocking element 500 is retained in the blocking position by a trigger element 600.
  • the Figure 28 represents a perspective view of this trigger element 600.
  • This trigger element 600 is advantageously pivotally mounted on the body 10 around an axis C (visible on the figures 16 And 18 ), between a locking position, in which it blocks said blocking element 500 in its blocking position, and a release position, in which it no longer blocks said blocking element 500.
  • axes B and C are parallel.
  • the blocking element 500 and the trigger element 600 together define a lock.
  • said trigger element 600 comprises a locking shoulder 610 which, in the locking position, cooperates with a locking projection 510 of the blocking element 500, preventing the pivoting of said blocking element 500 out of its blocking position.
  • said trigger element 600 when said trigger element 600 is in the locking position, it prevents the movement of the blocking element 500 towards its actuation position, which blocks the axial movement of the reservoir 100 and therefore the actuation of the dosing valve 200 .
  • the blocking system of the present invention therefore comprises two stages: a first stage formed by the lock between the blocking element 500 and the trigger element 600, and a second stage formed by the blocking between the blocking element 500 and the actuating member 800.
  • This blocking system allows the unlocking of a large effort (typically around 40-45N) by a small effort generated by inhalation.
  • the blocking element 500 stops the translation of the actuating member 800 when it is subjected to a force F (of 45N for example) by the support of the spring 850 on the actuating member 800 via the pushing member 810.
  • This blocking element 500 interacts with the trigger element 600 and is blocked/released by it.
  • the movement of said trigger element 600 is controlled by inhalation.
  • the geometry of the blocking system allows a very significant amplification (unlocking force/unlocking force), typically of the order of 100.
  • the axial force F generated by the spring 850 on the actuating member 800 is applied by the axial projections 801 of the actuating member 800 on the blocking element 500 at the level of the extensions 501, with the effect of urging said blocking element 500 to rotate in a first direction S1, visible on the Figure 16 , which reinforces the closed position of the lock and makes it stable.
  • the unlocking force generated by inhalation is applied to the trigger element 600 by the inhalation-sensitive member 60, preferably at a point 630 distant from the axis of the pivot C. This unlocking force aims to make turn said trigger element 600 in the direction S2 opposite to S1, as illustrated in the Figure 17 .
  • the torque that the blocking element 500 experiences is controlled by the distance d between the axis of effort on which the force F is applied to the blocking extensions 501 of the blocking element and the pivot axis B of said blocking element 500.
  • This distance d visible on the Figure 16 , is non-zero, and is less than 2 mm, advantageously less than 1 mm.
  • the torque that the trigger element 600 experiences is controlled by the distance d' between the axis of effort carrying the force F' that the trigger element 600 experiences from the blocking element 500 and the axis of pivot C of said trigger element 600.
  • d' the distance between the axis of effort carrying the force F' that the trigger element 600 experiences from the blocking element 500 and the axis of pivot C of said trigger element 600.
  • the force necessary to rotate the trigger element 600 is very low and can be generated by the organ sensitive to inhalation 60, which makes it possible to transform the depression generated by the inhalation in unlocking force.
  • the mouthpiece 400 comprises one or more opening(s) 410 connected with the interior of the body 10.
  • This at least one opening 410 is closed at rest and at the start of inhalation by a valve 420, so that the inhalation flow is initially mainly transmitted to the system of triggering by inhalation, in this example the deformable air chamber 60.
  • the blocking element 500 moves towards its actuation position under the effect of inhalation, and therefore the reservoir 100 moves axially relative to the body 10 to actuate the dosing valve 200 to distribute a dose of fluid product
  • said actuating member 800 or alternatively said reservoir 100, moves said valve 420 towards an open position.
  • said at least one opening 410 When said at least one opening 410 is thus open, during actuation, a draft of air is generated, which makes it possible to increase the inhalation flow. This optimizes the synchronization between dose delivery and user inhalation, and promotes good dose distribution in the user's lungs.
  • the trigger element 600 can be accessible from outside the body 10. This makes it possible, if necessary, to manually move the trigger element 600, to be able to actuate the dosing valve 200 even without inhalation, for example if the person who must receive the dose of fluid product is unable to achieve sufficient inhalation. It is therefore a matter of security. This also makes it possible to prime the valve, if it is a conventional valve requiring such priming.
  • the organ sensitive to inhalation 60 is produced in the form of a deformable air chamber.
  • this air chamber comprises a deformable membrane which is connected on the one hand to said body 10 and on the other hand to said trigger element 600.
  • the membrane has a bellows shape and forms a chamber noticeably waterproof. Other shapes are possible, including a simple pocket or diaphragm.
  • a stud can fix said membrane to an orifice or edge 630 of said trigger element 600.
  • the deformable membrane deforms and/or contracts under the effect of the depression generated by inhalation, causing the trigger element 600 to move from its locking position towards its release position. This makes it possible to open the lock defined between the blocking element 500 and the trigger element 600, and therefore the movement of said blocking element 500 from its blocking position to its actuation position.
  • valve 200 is therefore only actuated at the time of inhalation, so that the dose of fluid product is expelled out of the distribution orifice simultaneously with inhalation.
  • the thrust member 810 In the rest position, with the cover 1 closed, the thrust member 810 is not in contact with the tank 100, as visible on the figure 1 . Thus, in this position, the force of the spring 850 is applied by the pushing member 810 on the actuating member 800, which transmits it to the cover 1. Thus, during storage of the device, no constraint is applied on the valve 200, which limits or even eliminates the risks of leaks and/or malfunction of said valve.
  • the user When the user wishes to use the device, he opens the cover 1. In doing so, he eliminates the axial blocking of the actuating member 800 by the cover 1 as well as the pivoting blocking of the blocking element 500 by the cover 1. In this position, the actuating member 800 is blocked and prevented from sliding axially in the body 10 by the blocking extensions 501 of the blocking element 500 which axially block the axial projections 801 of the member d 800 actuation. As visible on the figure 2 , in this armed position (open cover, before inhalation), the thrust member 810 is still not in contact with the reservoir 100. Thus, in this position also, the force of the spring 850 is applied by the pressure member.
  • the actuator 800 (or alternatively the reservoir 100) will open the valve 420.
  • the device advantageously comprises signaling means to signal to the user that he must close the cover 1.
  • signaling means may include a visual indicator, as illustrated on the figures 6 and 7 .
  • a window 15 is formed in the body 10, through which a colored part of the actuator 800 is visible from the outside, forming an indication means.
  • the window 15 can indicate a light color, for example green, whereas after inhalation, it is a dark color, for example red which can be displayed in window 15.
  • a light color for example green
  • a dark color for example red which can be displayed in window 15.
  • any other similar implementation is possible.
  • the window (or windows) 15 can be positioned differently on the device, for example in the upper part of the body 10 or on the cover 11.
  • the indication means which are displayed in window 15 may alternatively include symbols, numbers, letters or any other useful indication to warn the user.
  • These indication means can be formed, for example formed by pad printing, directly on the actuating member 800, or be formed on a part attached to it.
  • the indication means can be produced on any other moving part during actuation, for example the pushing member 810, the blocking element 500, the trigger element 600, the inhalation sensitive member 60 .
  • the signaling means may include an audible indicator, such as a loudspeaker, which emits a sound audible to the user to indicate that the cover 1 must be closed.
  • an audible indicator such as a loudspeaker
  • the actuating member 800 When the user closes the cover 1, the actuating member 800 is pushed axially by said cover 1 towards its rest position, so that said reservoir 100 can rise axially in the body 10 towards its rest position under the effect of the return spring of the valve 200, and simultaneously the valve 210 of the dosing valve returns to the rest position, loading a new dose of fluid product into the valve chamber.
  • the trigger element 600 is returned to its initial position, in particular by the elasticity of the membrane.
  • the blocking element 500 returns to its blocking position.
  • the device is then ready for another use.
  • the final assembly of the device is simplified for the pharmaceutical laboratory which markets the device. Indeed, in most existing devices, the reservoir filled with active principle is inserted into the body and then several parts must be positioned above the reservoir, which does not facilitate production rates and ease of assembly.
  • the present invention advantageously provides for pre-assembling the sub-assembly formed of the thrust member 810, the spring 850 and the cover 11. This sub-assembly is pre-stressed during the assembly of these three parts , for example by coming with a hot tool O to thermally deform the lower axial edge 111 of a central axial sleeve 110 of the cover 11, around which the thrust member 810 and the spring 850 are assembled.
  • Said lower axial edge 111 is thus deformed to produce a retention collar which retains the thrust member 810 and the spring 850 in the cover 11.
  • This subassembly thus formed can then be assembled on the body 10 in a single assembly operation, for example by screwing or by snap-in. This then results in only two operations on the assembly line of the pharmaceutical laboratory: the insertion of the reservoir 100 into the body 10 ( figure 8 ) and the assembly of said sub-assembly on said body 10 ( Figure 9 ).
  • the actuating member 800 placed in the body 10 will cooperate with the pushing member 810, to push it axially into the cover 11 and thus load the spring 850.
  • this system can also allow the tank to be changed. Indeed, the device could be reusable and rechargeable for ecological reasons, in particular to avoid throwing away too many plastic components and/or too many electronic components.
  • the device comprises an automatic valve release system, which automatically returns the valve 210 of the valve 200 to its rest position after actuation of the valve, independently of the position of the cover 1 and the position of the valve member. actuation 800.
  • an automatic valve release system which automatically returns the valve 210 of the valve 200 to its rest position after actuation of the valve, independently of the position of the cover 1 and the position of the valve member. actuation 800.
  • the thrust element 910 is intended to come into contact with the reservoir 100, and is connected to the thrust member 810, with the interposition of the lever spring 920.
  • the thrust element 910 is very slightly offset axially of the reservoir 100, so that in this position, it does not transmit any stress to said reservoir 100 or to the valve 200. It is only when the user inhales, and releases the axial movement of the actuating member 800 , that the thrust element 910 will come into contact with the reservoir 100.
  • Each lever 901, 902 is assembled via studs 905 in a pivoting manner in a cam 815 of the thrust member 810 and cooperates with said thrust element 910.
  • valve release system The purpose of the valve release system is therefore to release the transmission of the force of the spring 850 to the reservoir 100 after inhalation, to allow said reservoir 100 to return to its rest position independently of the actuator 800. This makes it possible to load the next dose into the valve 200 immediately after inhalation, when the device is still in the appropriate position for this loading, without risk of wrong dosage, for example in the event of forgetting to close the cover 1.
  • this valve release system In locked position, before inhalation, visible on the Figure 19 , the levers 901 and 902 rest on a shoulder 911 of the thrust element 910. On the opposite side, the levers are in contact with locking fingers 115 formed in the cover 11 and which extend axially downwards at from the bottom of said cover. These locking fingers 115 prevent the levers 901, 902 from pivoting out of contact with the shoulder 911 of the thrust element. In this position, the force of the spring 850 is therefore transmitted by the levers 901, 902 to the thrust element 910 and therefore to the reservoir 100.
  • the pushing member 810, the pushing element 910 and the levers 901, 902 When the actuator 800 arrives in the actuation position, with the valve 200 which has been actuated to distribute a dose, the pushing member 810, the pushing element 910 and the levers 901, 902 have slid axially downwards relative to cover 11, as visible on the Figure 20 . In this position, the levers 901, 902 no longer cooperate with the locking fingers 115 of the cover 11. They can then pivot in the pushing member 810 until they are no longer in contact with the shoulder 911 of the thrust element.
  • the release of the element of thrust 910 occurs after expulsion of the dose by the valve, but before the end of the actuation stroke thereof.
  • the valve release system should be actuated only after sufficient travel to ensure that dose delivery occurs. Due to the manufacturing tolerances of the parts, it may be advantageous to provide a buffer element between the thrust element 910 and the reservoir 100.
  • This buffer element which must slow down or offset the actuation of the valve release system, can be an elastic element, such as a spring or a compressible part, for example example in elastomer.
  • Its resistance must be on the one hand greater than the force of the spring of the valve 200 in the actuation position of the valve 210, so that it is first the valve 200 which is actuated before the buffer element deforms, and on the other hand less than the force of the spring 850 in the actuation position of the actuator member 800, to guarantee that the buffer element will compress at the end of the actuation stroke.
  • a buffer element formed by a cylinder or by a variable volume chamber, filled with air or a fluid, and provided with a leak orifice.
  • the device may include a dose counter 1000, represented on the figures 1 to 9 , which can be mechanical or electronic, advantageously assembled in the body 10.
  • a dose counter 1000 can be mechanical or electronic, advantageously assembled in the body 10.
  • This counter 1000 can in particular detect the movements of the actuator 800 or the reservoir 100.
  • the counter could be connected to a sensor, in particular a membrane sensor, which detects the distribution of the dose of fluid product, for example in the valve well.
  • Other means of activating such a counter are also possible, for example detecting the movement of the valve 210 of the metering valve 200 relative to the valve body.
  • the meter When the meter is electronic, it must be able to have enough electrical energy to operate throughout the storage period until its first use. The battery must then have sufficient capacity, for example to communicate with the user (display of the number of doses remaining) and/or with a third-party application, throughout its use and at least until the date of expiration of the medicine. To avoid too large a battery, you must reduce the consumption of the electronic card before first use. To do this, the electronics are advantageously immersed in a standby mode, which consumes little in energy, until the time of first use. To "wake up” the electronics, the user is asked to activate the device by inhaling the first dose (if the device is equipped with a non-priming valve) or by priming (if the device is equipped with a non-priming valve).
  • the first actuation has the effect of lowering the actuating member 800 into the body 10. A part of the actuating member 800 will then put pressure on a contactor 1010, as shown on the figures 2 to 5 , which has the effect of closing a current loop. The device then detects this change in intensity which will wake up the electronics and put the meter in normal operating state.
  • the device may include an accelerometer.
  • the device may also include means for transmitting signals to communicate remotely, in particular information relating to the actuations of the device.
  • the body and/or the cover and/or the meter may include a signal transmission module, to communicate remotely with any remote device.
  • Appropriate power supply means are advantageously provided.
  • the electronic module can comprise a card comprising an electrical switch which sends a pulse.
  • the module can also include a display and/or use a Bluetooth or Wifi connection to send information to an additional device.
  • Suitable sensors may be provided, such as flow and/or pressure sensors, to detect various parameters of the inhalation flow.
  • the switch can be actuated by the movement of the actuating member and/or the blocking element and/or the trigger element and/or the inhalation sensitive member.
  • these means of emitting signals make it possible to transmit each dose distribution in an absolutely reliable manner, for example to a doctor or any other person wishing to monitor the user's use of the inhalation device.
  • the inhalation synchronization device ensures that the user inhales each time the device is activated, and the counter records each dose dispensed, as well as various associated parameters, such as the timestamp of each dispense. The doctor can thus know very precisely the conditions of use of the device by the user.
  • the present invention is particularly applicable for the treatment of asthma attacks or COPD (Chronic Obstructive Pulmonary Disease) in use with formulations such as salbutamol, aclidinium, formoterol, tiotropium, budesonide, fluticasone, indacaterol, glycopyrronium, salmeterol, umeclidinium bromide , vilanterol, olodaterol, striverdi, or any combination of these formulations.
  • formulations such as salbutamol, aclidinium, formoterol, tiotropium, budesonide, fluticasone, indacaterol, glycopyrronium, salmeterol, umeclidinium bromide , vilanterol, olodaterol, striverdi, or any combination of these formulations.

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Claims (11)

  1. Vorrichtung zur inhalationssynchronisierten Abgabe eines flüssigen Produkts, umfassend einen mit einem Mundstück (400) versehenen Körper (10), einen ein flüssiges Produkt und ein Treibgas enthaltenen Produktvorratsbehälter (100), welcher bezüglich des Körpers (10) axial verschiebbar angeordnet ist, ein an dem Vorratsbehälter (100) angebrachtes Dosierventil (200) mit einem zwischen einer Ruhestellung und einer Betätigungsstellung verschiebbaren Ventil (210), zur selektiven Abgabe des flüssigen Produkts bei jeder Betätigung, wobei die Vorrichtung folgendes umfasst:
    - ein Sperrelement (500), das zwischen einer Sperrstellung, in der das Dosierventil (200) nicht betätigbar ist, und einer Betätigungsstellung, in der das Dosierventil (200) betätigbar ist, verschiebbar und/oder verformbar ist,
    - ein Auslöseelement (600), das zwischen einer Verriegelungsstellung, in der es das Sperrelement (500) in dessen Sperrstellung blockiert, und einer Freigabestellung, in der es das Sperrelement (500) nicht blockiert, beweglich und/oder verformbar ist,
    - eine inhalationsgesteuerte Auslöseeinrichtung mit einem auf Inhalation ansprechenden Element (60), das durch Inhalation verformbar und/oder verschiebbar ist, wobei das auf Inhalation ansprechende Element (60) mit dem Auslöseelement (600) derart zusammenwirkt, dass bei Verformung und/oder Verschiebung des auf Inhalation ansprechenden Elements (60) letzteres das Auslöseelement (600) in dessen Freigabestellung verschiebt und/oder verformt, sodass sich dann das Sperrelement (500) aus der Sperrstellung in die Betätigungsstellung verschieben und/oder verformen lässt,
    - ein Betätigungselement (800), das mit dem Sperrelement (500) zusammenwirkt, sodass in der Sperrstellung des Sperrelements (500) das Sperrelement (500) eine axiale Bewegung des Betätigungselements (800) verhindert, und in der Betätigungsstellung des Sperrelements (500) das Sperrelement (500) eine axiale Bewegung des Betätigungselements (800) zulässt,
    dadurch gekennzeichnet, dass die Vorrichtung folgendes umfasst:
    - einen Deckel (11) mit einer axialen Mittelhülse (110), die mit einem unteren axialen Rand (111) versehen ist,
    - ein Drückerelement (810), das in dem Deckel (11) axial verschiebbar um die axiale Mittelhülse (110) herum angeordnet und zum Zusammenwirken mit dem Betätigungselement (800) und dem Vorratsbehälter (100) vorgesehen ist,
    - eine Feder (850), die um die axiale Mittelhülse (110) herum zwischen einem Boden des Deckels (11) und dem Drückerelement (810) angeordnet ist, wobei nach Anordnung des Drückerelements (810) und der Feder (850) um die axiale Mittelhülse (110) herum eine Verformung des unteren axialen Rands (111) der axialen Mittelhülse (110) erfolgt, wodurch ein Halteflansch des Drückerelements (810) entsteht und somit eine vormontierte Baugruppe gebildet wird, wobei die vormontierte Baugruppe anschließend an dem Körper (10) befestigt, insbesondere auf diesen aufgeschraubt oder eingerastet, wird.
  2. Vorrichtung nach Anspruch 1, bei der die Vorrichtung eine Abdeckung (1) aufweist, die zwischen einer Stellung zum Verschließen des Mundstücks (400) und einer Stellung zum Öffnen des Mundstücks (400) an dem Körper (10) beweglich, insbesondere verschwenkbar, gelagert ist, wobei die Abdeckung (1) mit dem Betätigungselement (800) derart zusammenwirkt, dass sie in der Verschließstellung das Betätigungselement (800) gegen eine axiale Verschiebung im Körper (10) sperrt und sie bei der Zurückbewegung aus ihrer Öffnungsstellung in ihre Verschließstellung das Betätigungselement (800) durch erneutes Belasten der Feder (850) in dessen Ruhestellung zurückbewegt.
  3. Vorrichtung nach Anspruch 1 oder 2, bei der das Sperrelement (500) um eine Schwenkachse (B) herum schwenkbar an dem Körper (10) gelagert ist und das Auslöseelement (600) um eine Schwenkachse (C) herum schwenkbar an dem Körper (10) gelagert ist, wobei die Achsen (B) und (C) parallel zueinander verlaufen.
  4. Vorrichtung nach einem der vorhergehenden Ansprüche, bei der der untere axiale Rand (111) mittels eines Heizwerkzeugs (O) thermisch verformt wird.
  5. Vorrichtung nach einem der vorhergehenden Ansprüche, umfassend eine Anzeige (15), die dem Benutzer anzeigt, dass die Abgabe von flüssigem Produkt erfolgt ist.
  6. Vorrichtung nach Anspruch 5, bei der es sich bei der Anzeige um eine visuelle und/oder eine akustische Anzeige handelt.
  7. Vorrichtung nach einem der vorhergehenden Ansprüche, umfassend einen elektronischen Zähler (1000).
  8. Verfahren zum Zusammenbau einer Vorrichtung zur inhalationssynchronisierten Abgabe eines flüssigen Produkts, wobei die Vorrichtung Folgendes umfasst:
    - einen mit einem Mundstück (400) versehenen Körper (10),
    - einen ein flüssiges Produkt und ein Treibgas enthaltenen Produktvorratsbehälter (100), welcher bezüglich des Körpers (10) axial verschiebbar angeordnet ist,
    - ein an dem genannten Vorratsbehälter (100) angebrachtes Dosierventil (200) mit einem zwischen einer Ruhestellung und einer Betätigungsstellung verschiebbaren Ventil (210), zur selektiven Abgabe des flüssigen Produkts bei jeder Betätigung,
    - ein Sperrelement (500), das zwischen einer Sperrstellung, in der das Dosierventil (200) nicht betätigbar ist, und einer Betätigungsstellung, in der das Dosierventil (200) betätigbar ist, verschiebbar und/oder verformbar ist,
    - ein Auslöseelement (600), das zwischen einer Verriegelungsstellung, in der es das Sperrelement (500) in dessen Sperrstellung blockiert, und einer Freigabestellung, in der es das Sperrelement (500) nicht blockiert, beweglich und/oder verformbar ist,
    - eine inhalationsgesteuertes Auslöseeinrichtung mit einem auf Inhalation ansprechenden Element (60), das durch Inhalation verformbar und/oder verschiebbar ist, wobei das auf Inhalation ansprechende Element (60) mit dem Auslöseelement (600) derart zusammenwirkt, dass bei Verformung und/oder Verschiebung des auf Inhalation ansprechenden Elements (60) letzereres das Auslöseelement (600) zu dessen Freigabestellung hin verschiebt und/oder verformt, sodass sich dann das Sperrelement (500) aus der Sperrstellung in die Betätigungsstellung verschieben und/oder verformen lässt,
    - ein Betätigungselement (800), das mit dem Sperrelement (500) zusammenwirkt, sodass in der Sperrstellung des Sperrelements (500) das Sperrelement (500) eine axiale Bewegung des Betätigungselements (800) verhindert, und in der Betätigungsstellung des Sperrelements (500) das Sperrelement (500) eine axiale Bewegung des Betätigungselements (800) zulässt,
    - einen Deckel (11) mit einer axialen Mittelhülse (110), die mit einem unteren axialen Rand (111) versehen ist,
    - ein Drückerelement (810), das in dem Deckel (11) axial verschiebbar um die axiale Mittelhülse (110) herum angeordnet und zum Zusammenwirken mit dem Betätigungselement (800) und dem Vorratsbehälter (100) vorgesehen ist,
    - eine Feder (850), die um die axiale Mittelhülse (110) herum zwischen einem Boden des Deckels (11) und dem Drückerelement (810) angeordnet ist,
    dadurch gekennzeichnet, dass das Verfahren die folgenden Schritte umfasst:
    - Anbringen der Feder (850) um die axiale Mittelhülse (110) herum,
    - Anbringen des Drückerelements (810) um die axiale Mittelhülse (110) herum,
    - Verformen des unteren axialen Rands (111) der axialen Mittelhülse (110) zur Erzeugung eines Halteflanschs für das Drückerelement (810) und somit zur Bildung einer vormontierten Baugruppe,
    - Einsetzen des Vorratsbehälters (100) in den Körper (10), und
    - Befestigen der genannten vormontierten Baugruppe an dem genannten Körper (10).
  9. Verfahren nach Anspruch 8, bei dem der Schritt des Befestigens der vormontierten Baugruppe an dem Körper (10) durch Aufschrauben oder Einrasten erfolgt.
  10. Verfahren nach Anspruch 8 oder 9, bei dem der Schritt des Verformens des unteren axialen Randes (111) der axialen Mittelhülse (110) mittels eines beheizten Werkzeugs (O) erfolgt, mit dem der untere axiale Rand (111) thermisch verformt wird.
  11. Verfahren nach einem der Ansprüche 8 bis 10, bei dem im Schritt des Befestigens der vormontierten Baugruppe an dem Körper (10) das Betätigungselement (800) mit dem Drückerelement (810) zusammenwirkt, um zur Belastung der Feder (850) das Drückerelement (810) axial in den Deckel (11) hinein zu drücken.
EP20707723.1A 2019-02-04 2020-02-03 Vorrichtung zur ausgabe eines mit inhalation synchronisierten flüssigproduktes und verfahren zum zusammenbau dieser vorrichtung Active EP4100088B1 (de)

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FR1901079A FR3092251B1 (fr) 2019-02-04 2019-02-04 Dispositif de distribution de produit fluide synchronisé avec l'inhalation et procédé d'assemblage dudit dispositif
PCT/FR2020/050173 WO2020161423A1 (fr) 2019-02-04 2020-02-03 Dispositif de distribution de produit fluide synchronisé avec l'inhalation et procédé d'assemblage dudit dispositif

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JP2022519600A (ja) 2022-03-24
WO2020161423A1 (fr) 2020-08-13
FR3092251B1 (fr) 2021-01-22
FR3092251A1 (fr) 2020-08-07
US20220096761A1 (en) 2022-03-31
CN113382762A (zh) 2021-09-10

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